LXE408 Novartis for CL
Assess the suitability of LXE408 for the treatment of patients with localized cutaneous leishmaniasis
current phase of drug development
updated 3 Mar 2026
LXE408 is a selective, pan-kinetoplastid proteasome inhibitor discovered at Novartis with financial support from Wellcome. It has potent anti-parasitic activity against all kinetoplastid parasites tested to date, which include Leishmania species that cause visceral (L. donovani, L. infantum) and cutaneous leishmaniasis (including L. major and L. braziliensis) as well as Trypanosoma species that cause Chagas disease (T. cruzi) and human African trypanosomiasis (T. brucei).
The efficacy, safety, and pharmacokinetics of LXE408 are being evaluated in patients with visceral leishmaniasis in two ongoing Phase II studies in India and Ethiopia.
In a Phase II, randomized, multicentre, observer-blinded study, DNDi and partners will evaluate the safety, efficacy, and pharmacokinetic profile of two oral LXE408 regimens compared with oral miltefosine as the active control in patients with localized cutaneous leishmaniasis in the region of the Americas, and assess the suitability of LXE408 for use in monotherapy for the treatment of patients with cutaneous leishmaniasis.
2025
The protocol and supporting documents for the Phase II trial evaluating the safety, efficacy, and pharmacokinetic profile of two oral LXE408 regimens were submitted to the regulatory authorities in Brazil and Panama, and approvals were obtained from both countries. Ethics approvals are expected in the first quarter of 2026; and study initiation is expected to follow in the second quarter. DNDi teams made progress developing key study documents, including the case report form and manual of operations, and these are expected to be finalized by the time ethical approvals are received. In addition, the vendor selection process for data management, interactive response technology, statistics, and central depot has been completed.
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